Essential Elements for a GMP Analytical Chemistry Department
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Beschreibung
Introduction.- Organization.- Department Structure.- Project Teams.- Responsibilities.- Interactions.- Operating Guidance's.- Processes.- Safety.- Technology.- Department.- Statistical Concepts for the Analytical Chemist.- Data distribution.- Significance Testing.- Confidence Intervals.- Outliers in analytical data.- Regression.- Experimental design.- Required sample replicates.- Method performance.- Uncertainty measurement.- Sampling strategies.- Outsourcing.- Process.- Audit Check List.- Documentation.- Sample Submission.- Technical Report.- Reports of analysis.- Records (Training etc.).- Job Descriptions.- Career Tracks.- Motivating Personnel.- Career Path.- Hiring the Best.
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